Cannabis THC Potency, Metabolism, and Cognitive Impairment in Young Adults

NCT ID: NCT06077292

Last Updated: 2025-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-17

Study Completion Date

2026-03-14

Brief Summary

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The goal of this interventional study is to determine the impact of high potency THC product use on cognitive function of young adults aged 21-25.

The main question it aims to answer is: will cannabis users who switch to less potent THC products demonstrate improved cognitive function compared to baseline?

Other questions this study aims to answer include:

* Can researchers accurately assess THC consumption among frequent cannabis users?
* Can researchers effectively incentivize cannabis users to use less potent THC products?
* Do genetic variations in THC metabolism impact urinary THC excretion?
* Do genetic variations in THC metabolism impact cognitive performance in cannabis users?
* Are quantitative urinary THC values predictive of cognitive impairment?
* How can researchers use research findings to inform harm reduction practices for people who use cannabis?

Participants will submit blood and urine samples and be incentivized to use less potent THC products.

Detailed Description

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The goal of this interventional study is to determine the impact of high potency THC product use on cognitive function of young adults aged 21-25.

The aims aims of this study are:

1. Evaluate feasibility of assessing THC consumption, genetic variation in THC metabolism, urinary THC excretion, and cognitive performance in users of high potency cannabis products.
2. Test the effectiveness of an incentivization protocol aimed at encouraging cannabis users to use less potent THC products as a means of harm reduction.
3. Compare group differences between the high and low THC-reduction groups on THC metabolism (urine) and cognitive performance while controlling for any changes in frequency and amount of cannabis used.
4. Identify whether participant predisposition to poorly metabolize THC (i.e., CYP2C9\*3 carriers vs. others) impacts urinary THC excretion in the experimental condition relative to baseline in both groups.
5. Identify whether participant predisposition to poorly metabolize THC (i.e., CYP2C9\*3 carriers vs. others) impacts cognitive performance in the experimental condition relative to baseline in both groups.
6. Determine whether quantitative urinary THC values correlate with measures of cognitive performance.
7. Communicate basic findings regarding relationships between variables and outcomes in the form of a scorecard to help provide harm reduction strategies for youth who use cannabis.

Participants will:

* Undergo a baseline assessment of cognitive performance and will submit blood and urine samples to assess genetic variation in THC metabolism, and baseline urinary THC excretion.
* Be randomized to two groups: 1) lower THC reduction group (incentivized to use THC products that are at least 15% less potent than baseline) and 2) higher THC reduction group (incentivized to use THC products that are at least 35% less potent than baseline) .
* Submit urine samples at baseline and weekly for 5 weeks to measure urinary THC excretion.
* Complete weekly follow up surveys assessing cannabis use patterns, reinforcing value of the cannabis product(s) used, symptoms of cannabis withdrawal, and presence of positive and negative emotions.
* Undergo re-assessment of cognitive performance after 5 weeks of intervention.

Researchers will compare if participants in each group are able to use less potent THC products and whether the use of less potent THC products results in improved cognitive function.

Conditions

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Cannabis Use THC Marijuana Use Cognitive Impairment THC Vaping

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Investigators

Study Groups

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15% THC Potency Reduction Group

Participants will be incentivized to use THC products that are at least 15% less potent than baseline

Group Type EXPERIMENTAL

15% THC Potency Reduction

Intervention Type BEHAVIORAL

Participants will be incentivized to use THC products that are at least 15% less potent than baseline

35% THC Potency Reduction Group

Participants will be incentivized to use THC products that are at least 35% less potent than baseline

Group Type EXPERIMENTAL

35% THC Potency Reduction

Intervention Type BEHAVIORAL

Participants will be incentivized to use THC products that are at least 35% less potent than baseline

Interventions

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15% THC Potency Reduction

Participants will be incentivized to use THC products that are at least 15% less potent than baseline

Intervention Type BEHAVIORAL

35% THC Potency Reduction

Participants will be incentivized to use THC products that are at least 35% less potent than baseline

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 21-25
* Resides in San Francisco
* Self-report cannabis concentrate use as their primary method of cannabis use
* Self-report using cannabis daily or almost daily (i.e., at least 6 out of 7 days during each of the last 4 weeks)
* Self-report only purchasing cannabis from regulated retail stores in California.

Exclusion Criteria

* Pregnant
* Regularly uses other drugs (other than nicotine)
Minimum Eligible Age

21 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Advocates for Human Potential

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Veronika Mesheriakova, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Michael Sofis, PhD

Role: PRINCIPAL_INVESTIGATOR

Cannabis Public Policy Consulting

Locations

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University of California San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Alison Giovanelli, PhD

Role: CONTACT

415-476-4575

Facility Contacts

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Louie Swander

Role: primary

References

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Sachse-Seeboth C, Pfeil J, Sehrt D, Meineke I, Tzvetkov M, Bruns E, Poser W, Vormfelde SV, Brockmoller J. Interindividual variation in the pharmacokinetics of Delta9-tetrahydrocannabinol as related to genetic polymorphisms in CYP2C9. Clin Pharmacol Ther. 2009 Mar;85(3):273-6. doi: 10.1038/clpt.2008.213. Epub 2008 Nov 12.

Reference Type BACKGROUND
PMID: 19005461 (View on PubMed)

Murray RM, Quigley H, Quattrone D, Englund A, Di Forti M. Traditional marijuana, high-potency cannabis and synthetic cannabinoids: increasing risk for psychosis. World Psychiatry. 2016 Oct;15(3):195-204. doi: 10.1002/wps.20341.

Reference Type BACKGROUND
PMID: 27717258 (View on PubMed)

Ramaekers JG, Kauert G, van Ruitenbeek P, Theunissen EL, Schneider E, Moeller MR. High-potency marijuana impairs executive function and inhibitory motor control. Neuropsychopharmacology. 2006 Oct;31(10):2296-303. doi: 10.1038/sj.npp.1301068. Epub 2006 Mar 29.

Reference Type BACKGROUND
PMID: 16572123 (View on PubMed)

D'Souza DC, Ganesh S, Cortes-Briones J, Campbell MH, Emmanuel MK. Characterizing psychosis-relevant phenomena and cognitive function in a unique population with isolated, chronic and very heavy cannabis exposure. Psychol Med. 2020 Oct;50(14):2452-2459. doi: 10.1017/S0033291719002721. Epub 2019 Oct 16.

Reference Type BACKGROUND
PMID: 31615592 (View on PubMed)

Bidwell LC, Martin-Willett R, Karoly HC. Advancing the science on cannabis concentrates and behavioural health. Drug Alcohol Rev. 2021 Sep;40(6):900-913. doi: 10.1111/dar.13281. Epub 2021 Mar 30.

Reference Type BACKGROUND
PMID: 33783029 (View on PubMed)

Bourque J, Potvin S. Cannabis and Cognitive Functioning: From Acute to Residual Effects, From Randomized Controlled Trials to Prospective Designs. Front Psychiatry. 2021 Jun 10;12:596601. doi: 10.3389/fpsyt.2021.596601. eCollection 2021.

Reference Type BACKGROUND
PMID: 34177633 (View on PubMed)

Other Identifiers

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23-39581

Identifier Type: -

Identifier Source: org_study_id

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